Cosmetic skin rejuvenation

ABSTRACT

A cosmetic method for treating a skin of a person is presented, the method comprises inserting one or more needles to one or more depths into the skin of the person such that at least a tip of at least one needle of the one or more needles is deployed within a muscle layer of the person&#39;s skin; applying a negative DC voltage to the one or more needles, while a skin of the person is in contact with a positive electrode to form one or more closed circuits of DC current through the person&#39;s body; and providing the DC current for a pre-selected amount of time to damage and/or ablate muscles and/or muscle nerve cells in the muscle layer; thereby providing a skin treatment comprising reducing and/or smoothing wrinkles from the person&#39;s skin.

RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 15/422,557, filed Feb. 2, 2017, which is a divisional application ofU.S. application Ser. No. 13/388,521, filed Feb. 2, 2012, now U.S. Pat.No. 9,596,920, issued on Mar. 21, 2017, which is a U.S national stageapplication of PCT Application Serial No. PCT/IL10/00583, filed Jul. 21,2010, which claims the benefit of priority from U.S. ProvisionalApplication No. 61/231,033 filed Aug. 4, 2009. The entire contents ofthese disclosures are hereby incorporated by reference in theirentirety.

FIELD OF THE INVENTION

The present invention relates generally to skin rejuvenation forcosmetic purposes and more specifically to performing skin rejuvenationthrough the use of electromagnetic energy.

BACKGROUND OF THE INVENTION

Skin is the primary barrier that withstands environmental impact on aperson's body. The environmental impact results from elements such assun, cold, wind, humidity and other conditions. The environmentalfactors along with aging cause the skin to lose its youthful look anddevelop wrinkles. This phenomenon is known as skin aging.

FIG. 1 is a schematic illustration of a side sectional view of a pieceof human skin 100 and its underlying layers. Human skin 100 is made upfrom the epidermis 20, which is about 100 μm thick including itsoutermost layer the stratum corneum 10. The epidermis is followed by thedermis 30, which may extend up to about 4 mm from the surface.Subcutaneous layer 40 is located under dermis 30. These three layerscontrol the overall external appearance of the skin (e.g. youthful oraged). The dermis 30 is made up of elastin, collagen 70,glycosoaminoglycans, and proteoglycans. The subcutaneous layer 40includes fatty areas with fibrous vertical bands that course through itand form a link between dermal collagen 70 and subcutaneous layer 40.Collagen 70 provides the resilience and elasticity to skin. Age and sunexposure, reduce fibroplast metabolism and cause the collagen 70 to losetheir elasticity and tensile strength, so that the skin loses itsyouthful, tight appearance.

Below subcutaneous layer 40 are located muscles 50 and muscle nervesthat also contribute to the wrinkled appearance of the skin with age.

Numerous techniques have been described for skin rejuvenation bycounteracting the above phenomenon, for example:

The most popular and widely used treatments for skin rejuvenation aredermabrasion peels, laser peels and chemical peels. These types of peelscause mild injury to the skin that is not too deep but yet deep enoughto induce healing. The skin with its natural ability to repair itselfinitiates a process of rejuvenation thereby repairing the damage causedand improving the cosmetic appearance.

Dermabrasion is a method of removing skin by way of polishing orsanding. Once the old skin is abraded, a fresh layer of skin replacesthe old one which has been removed.

In chemical peeling, a chemical solution is applied to the skin thusprompting the upper most layer of skin to peel off. Once the old layerof skin is removed a fresh layer of skin, which is better in color andblemish free, is formed replacing the peeled off layer. Different typesof chemical peels enable achieving mild, moderate or deep peels suitablefor different patients needs. A mild peel is a procedure that removesthe superficial skin layer. This chemical peel involves a diluted acidsolution, which normally stays on the skin for a few minutes. The MediumPeel procedure goes a little beyond the superficial layer of the skin.The chemical solution, as compared to mild peels, is kept on the skinfor a longer time. Unlike the mild and medium-depth peel, a deepchemical peel penetrates deeper in the dermal layer to address morepronounced skin pigmentations and wrinkles.

One major disadvantage of these peeling methods is that after any peeland during the healing process, the treated area may become crustedresulting in skin pigmentation problems. Thus difficulties to controlthe depth of the peeling, possible pigment change, and risk of scarringare among the risks associated with chemical peeling.

The above mentioned methods suffer from being invasive and involvingsignificant discomfort, pain, downtime and potential side effects. Asthese cosmetic procedures are all elective procedures, pain and theoccasional side effects have been a significant deterrent to manypotential customers, who would otherwise like to deal with skinproblems.

To overcome some of the issues associated with the invasive procedures,laser and radio frequency energy based wrinkle reduction treatments havebeen proposed. For example, U.S. Pat. No. 6,387,089 describes aprocedure referred to as photo rejuvenation, wherein pulsed light isused for heating and shrinking the collagen and thereby restoring theelasticity of the skin. Since collagen is located in the dermis, lasersthat target collagen must penetrate through the epidermis and throughthe dermal epidermal junction. Due to Bier's Law of absorption, thelaser beam is typically most intense at the surface of the skin. Thisresults in unacceptable heating of the upper layers of the skin. Variousapproaches have been described to cool the upper layers of the skinwhile maintaining the layers underneath at the desired temperature. Oneapproach is to spray cryogen on the surface so that the surface remainscool while the underlying layers (and hence collagen) are heated. Suchan approach is described in U.S. Pat. No. 6,514,244. Another approachdescribed in U.S. Pat. No. 6,387,089 is the use of a cooled transparentsubstance, such as ice, gel or a crystal that is in contact with thesurface of the skin. The transparent nature of the coolant would allowthe laser beam to penetrate the different skin layers while maintainingan acceptable temperature level on the surface of the skin.

Photo rejuvenation requires the use of intense pulses of filtered light.The light penetrates the outer skin layers, causing them minimal damage,and is absorbed by deeper tissues. Photo rejuvenation is useful only intreating fine to moderate wrinkles.

Photo rejuvenation risks include swelling, scarring, blistering,hyper/hypo pigmentation, sensitivity to sun exposure and sensitivity tomake-up. Individuals with darker skin tones may suffer from hyperpigmentation for several months following treatment. During the recoverystage sun exposure must be avoided to minimize side effect such as hyperpigmentation.

Extensive sun exposure may lead to chronic UV irradiation. This appearsto trigger dysfunctional wound repair pathways in the skin that involvegradual replacement of normal epidermal and dermal structures withcharacteristic atrophy and accumulation of elastotic dermal matrixcomponents.

Currently, reversal of photo-aging is attempted by imparting cutaneousinjury that induces new dermal collagen formation. Such cutaneous injurycould be accomplished using mechanical (e.g., dermabrasion), chemical(e.g., retinoids and acid peels), or laser treatments. These cutaneousinjuries are expected to initiate normal fibro-proliferative responsesof the upper reticular and papillary dermal compartments, resulting inrejuvenated skin. U.S. Pat. No. 6,120,497 describes thermally injuringcollagen in the targeted dermal region to activate fibroblasts. Thefibroblasts in turn deposit increased amounts of extracellular matrixconstituents. However, epidermal injury associated with a mechanicalsurface ablation process such as dermabration or peeling. Promotes theinflammatory phase, which inhibits the rejuvenative process. Hence,while the currently used methods, which are mentioned above, forinitiating normal fibro-proliferative response of the dermalcompartments can yield rejuvenated skin, due to the epidermal injurythat occurs with these processes, the rejuvenative process iscompromised.

An objective of nonablative photorejuvination is to induce a thermalwound repair response in the papillary and upper reticular dermalcompartments (approximately 100-400 μm below the surface of the skin)while sparing the epidermal compartment. To spare the epidermis, onetypically uses low fluences (laser energy densities). Unfortunately,such low levels are generally inadequate to promote the kinds ofstimulation that are required to cause the desired dermal effect. Thus,prior art approaches result in low efficacy. In most cases, low dermalmatrix remodeling and clinical responses (e.g., wrinkle reduction,retexturing, dyschromia reduction, and telangiectasia removal) areachieved by these procedures. Thus there is an unmet need for sparingthe epidermal layer, but achieving enough stimulation of dermal matrixremodeling to be clinically effective.

To overcome some of the problems associated with the undesired heatingof the upper layers of the skin (epidermal and dermal), U.S. Pat. No.6,311,090 describes using RF energy and an arrangement comprising RFelectrodes that rest on the surface of the skin. A reverse thermalgradient is created that apparently does not substantially affectmelanocytes and other epithelial cells. However, even such non-invasivemethods have the significant limitation that energy cannot beeffectively focused in a specific region of interest, say, the dermis30.

Electrosurgical resurfacing involves the use of a micro-electrical radiofrequency that delivers energy to the skin. This treatment can beeffective in eliminating or improving minor to moderate skinimperfections.

Other approaches have been described to heat the dermis without heatingmore superficial layers. These involve using electrically conductiveneedles that penetrate the surface of the skin into the tissue andprovide heating. U.S. Pat. Nos. 6,277,116 and 6,920,883 describe suchsystems. Unfortunately, such an approach results in widespread heatingof the subcutaneous layer and potentially melting the fat in thesubcutaneous layer. This leads to undesired scarring of the tissue.

One approach that has been described to limit the general, uniformheating of the tissue is fractional treatment of the tissue, asdescribed in U.S. Patent Application publication No. 2005/0049582. Thisapplication describes the use of laser energy to create treatment zonesof desired shapes in the skin, where untreated, healthy tissue liesbetween the regions of treated tissue. This enables the untreated tissueto undergo a healing and recovery process.

As opposed to traditional laser resurfacing, which treats the wholesurface of the target tissue, fractional laser skin resurfacing usesfractional Photothermolysis. It targets tissue with a pattern ofdispersed spots. This results in a pattern of microscopic zones oftissue coagulation that heal over several weeks while the skin retainsnormal appearance. Rather than creating a global tissue effect at thesurface of the target tissue, or in the dermis alone, this methodcreates injury in a tiny fraction of the skin treated, coagulatingmultiple columns of tissue, 70-100 micron in diameter, extending throughthe epidermis and deep into the dermis reaching up to 1 mm depth. Theselaser columns create micro thermal zones of tissue coagulation which issurrounded by healthy tissue. The treated zone consists approximately15-20% of the surface. Tissue is not vaporized and the stratum corneum10 remains intact. The healthy tissue provides a generous reservoir ofstem cells and melanocytes in the papillary dermis that are spared fromwounding and accelerate the healing process. The small size of thewounds and the short migratory paths for keratinocytes from the sparedtissue result in rapid re-epitheliazation and fast epidermal repair.Zones of collagen denaturation in the dermis cause upregulation of theinflammatory cascade, which leads to collagen remodeling to depths of400-700 microns resulting in skin tightening. The fact that patients donot have open wounds leads to minimal downtime. Fractional laserresurfacing is therefore a non-ablative procedure offering a gentle yeteffective method for skin resurfacing at minimal patient downtime andminimum risk. It offers improved skin texture, tone, pigmentation, finelines and skin tightening. It claims to be safe for all skin types andcan be used on areas other than the face such as the neck, chest andhands which are more delicate and tend to scar. Fractional resurfacingrequires a series of 3-5 treatments as opposed to ablative lasers thatrequire a single treatment.

A disadvantage of fractional laser resurfacing is that in order toachieve dramatic results heating of the tissue reaches the temperaturein the necrotic zone which is around 70° C., and the tissue, whether itis made up primarily of cells, keratinocytes and their derivatives orcollagen, is necrosed or denatured, respectively. Temperatures in thetissue above 100° C. may cause steam to form in the tissue, which maycause disruptive effects. Such temperatures may result in undesirableside effects such as pain, erythema, swelling, occasional scarring,extended healing times and infection.

Thus there is an unmet need for a fractional treatment that causestissue injury and triggers tissue healing processes but without therisks and complications caused by tissue heating that createsdenaturation and coagulation of tissue.

Another method of treating wrinkles includes the use of Botox. Botox isa toxin that is injected into the patient's muscles. The toxin blocksthe nerve impulses, temporarily paralyzing the muscles and causing themuscles to relax. As a result wrinkled skin is smoothed out. Thesmoothing effect is apparent almost immediately and improves over thenext few days. Generally the effects of a Botox injection last forbetween 3 to 6 months depending on the severity of the wrinkles and onthe dosage of Botox used.

SUMMARY OF THE INVENTION

An aspect of an embodiment of the invention, relates to an apparatus andmethod for cosmetically treating various internal layers of the skin toachieve improved and more youthful appearance of the skin. The method isbased on the use of a needle electrode that is inserted into selecteddepths in a person's skin and applying a negative DC voltage to theneedle. Optionally, the selected depths are below the position of thehair follicles to deal with deeper elements of skin 100 that are notdealt with by hair epilation. The DC voltage induces a cold chemicalprocess in the cells surrounding the needle causing selectivedestruction of cells. The chemical process forms Sodium Hydroxide (NaOH)by electrolysis and the Sodium Hydroxide then destroys surroundingcells. In some embodiments of the invention, the apparatus furtherincludes an RF transmitter that is coupled to the needle and positionedabove the surface of the skin while applying the DC voltage, to heat thetreated area and resulting solution, thereby accelerating the chemicalprocess.

In some embodiments of the invention, the needle is hollow to allow forthe provision of saline or other substances (e.g. anesthetics,lidocaine, epinephrine, growth factors, stem cells, botulinum toxin) tothe position at which the DC voltage is applied to accelerate thechemical process. Optionally, the hollow needle may also serve as asuction for removing fluids.

In some embodiments of the invention, part of the needle is covered withan insulation to limit the area that is in contact with skin cells andproviding negative charge, for example leaving only the tip of theneedle non-insolated.

In some embodiments of the invention, the needle serves as a sensor tomeasure resistance, so that user can determine the skin layer located atthe tip of the needle.

In an exemplary embodiment of the invention, the needle is positioned todamage muscles and muscle nerve cells, so that the muscles will becomelapse and cause wrinkles to disappear. Alternatively or additionally,the needle is positioned to damage fat cells in the subcutaneous layerto reduce the thickness of the skin. Optionally, liquid formed by thedamaged fat cells is removed by suction. In some embodiments of theinvention, the needle is positioned to damage collagen fibers so thatthey may be rejuvenated. One of the advantages of the use of a needlewith DC voltage is that the damage is pin pointed to the positionsurrounding the needle, thereby enabling precise damage to a desiredarea.

There is thus provided according to an exemplary embodiment of theinvention, a device for cosmetic treatment of human skin, including:

a needle for inserting into the skin;

a DC power source electrically connected to the needle for providingnegative current to the needle;

an anode that is electrically connected to the DC power source toreceive positive current, and that is adapted to be placed in contactwith the skin of the person into which the needle is inserted to form aclosed electrical circuit;

at least one RF transmitter coupled to the needle for radiating the areaaround where the needle is inserted to provide heat while the needle isdeployed.

In an exemplary embodiment of the invention, the needle is hollow toenable transfer of fluid into the skin or out of the skin while theneedle is deployed. Optionally, the device includes a syringe to injectfluid through the needle. In an exemplary embodiment of the invention,the device includes a motor to control the injection of fluid from thesyringe. Optionally, the device includes a resistance sensor to measurethe resistance in the DC circuit responsive to the position of theneedle in the skin. In an exemplary embodiment of the invention, thedevice is adapted to provide an indication regarding the measuredresistance. Optionally, the device includes a display to provideinformation to a user. In an exemplary embodiment of the invention, thedevice includes one or more dials to accept information from a user.Optionally, the device is adapted to automatically control the timing ofthe provision of DC current and RF radiation. Optionally, the timing isuser selectable. In an exemplary embodiment of the invention, the deviceis adapted to provide DC current and RF radiation simultaneously.Alternatively, the device is adapted to provide DC current and RFradiation intermittently. Optionally, the needle is partially insulated.In an exemplary embodiment of the invention, only the tip of the needleis not insulated.

In an exemplary embodiment of the invention, the device includes anarray of needles for inserting into the skin and serving as cathodescharged with current from the DC power source. Optionally, all theneedles are provided with the same current. Alternatively, some of theneedles are provided with a different current than the others. In anexemplary embodiment of the invention, the device includes an AC currentsource to generate the RF radiation.

There is further provided according to an exemplary embodiment of theinvention, a method of treating skin, including:

deploying a needle to a specific depth into a persons skin below theroots of the person's hair follicles;

applying a negative DC voltage to the needle, while the person is incontact with a positive electrode to form a closed circuit of DC currentthrough the person's body;

providing DC current for a pre-selected amount of time to induce achemical reaction that forms Sodium Hydroxide at the point of contact ofthe needle.

In an exemplary embodiment of the invention, the method includestransmitting RF radiation toward the deployed needle to heat up thedeployed area. Optionally, the transmitting and the providing areperformed simultaneously. Alternatively, the transmitting and theproviding are performed intermittently. In an exemplary embodiment ofthe invention, the method includes supplying liquids into the skinthrough a hollow conduit in the needle. Optionally, the deploying is ofan array of needles. In an exemplary embodiment of the invention, themethod includes measuring resistance of the circuit to determine thedepth of the needle. Optionally, the method includes providing anindication of the depth to the user. In an exemplary embodiment of theinvention, the needle is deployed so that its tip is located in thevicinity of the muscles below the subcutaneous layer. Alternatively, theneedle is deployed so that its tip is located in the vicinity of thecollagen fibers in the dermis. Further alternatively, the needle isdeployed so that its tip is located in the vicinity of fat cells in thesubcutaneous layer. Optionally, the resistance is measured before andafter treatment to determine the level of success of the treatment.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and better appreciated from thefollowing detailed description taken in conjunction with the drawings.Identical structures, elements or parts, which appear in more than onefigure, are generally labeled with the same or similar number in all thefigures in which they appear, wherein:

FIG. 1 is a schematic illustration of a side sectional view of skin andunderlying layers;

FIG. 2 is a schematic illustration of a device for treating skin,according to an exemplary embodiment of the invention;

FIG. 3 is a schematic illustration of an alternative handpiece with anarray of needles, according to an exemplary embodiment of the invention;

FIG. 4 is a flow diagram of a cosmetic skin treatment process, accordingto an exemplary embodiment of the invention;

FIG. 5 is a schematic illustration of a side sectional view of skin witha needle deployed for treating muscles below the subcutaneous layer,according to an exemplary embodiment of the invention;

FIG. 6 is a schematic illustration of a side sectional view of skin witha needle deployed for treating fatty areas in the subcutaneous layer,according to an exemplary embodiment of the invention;

FIG. 7 is a schematic illustration of a side sectional view of skin witha needle deployed for treating collagen in the dermal layer, accordingto an exemplary embodiment of the invention;

FIG. 8A is a schematic illustration of a single injection needleperforming electrolysis, according to an exemplary embodiment of theinvention; and

FIG. 8B is a schematic illustration of an array of injection needlesperforming electrolysis, according to an exemplary embodiment of theinvention.

DETAILED DESCRIPTION

FIG. 2 is a schematic illustration of a device 200 for treating skin100, according to an exemplary embodiment of the invention. In anexemplary embodiment of the invention, a negative electrode of a DCcircuit is provided as a needle 240 in device 200. The needle 240 isadapted to be inserted into the skin 100 of a person for performingelectrolysis. Optionally, the needle has a small diameter, for examplebetween 50-500 microns so that it does not cause noticeable damage tothe outer layer of the skin when inserted into the skin.

A person's skin 100 contains moisture made of water (H₂O) and salt(NaCl). The amount of moisture tends to rise the deeper you penetrateinto the skin, for example the dermis 30 tends to be more moist than theepidermis 20 and the fatty areas in the subcutaneous layer 40 tend to bemore moist than the dermis 30. The negative electric current causes someof the water and the salt molecules of the moisture to break up intoIons (Na⁺, Cl⁻, H⁻ and OH⁺). The positive Ions (Na⁺ and OH⁺) movetowards the negative electrode and recombine to form an AlkaliSodium-Hydroxide (NaOH). The Sodium-Hydroxide is highly caustic anddestroys cell tissue located in the area of needle 240 when the negativeDC voltage is applied.

The amount of Sodium Hydroxide, popularly referred to as units of Lye,depends on the current intensity and on the duration of applying thecurrent. A unit of Lye is defined as the product of applying a tenth ofa milliamp of current for 1 second. The moisture content of skin 100increases the conductivity so that if the moisture is higher currentwill flow faster and the production of Lye will be increased.

In an exemplary embodiment of the invention, needle 240 extends from ahandpiece 220, which can be held by the user to treat the skin 100 of aperson. Optionally, needle 240 is hollow forming a conduit, andhandpiece 220 includes a syringe 236, which can be filled with a liquid,for example saline from an external container 235. During application ofcurrent to the needle, syringe 236 may deliver liquid through the hollowof needle 240 to its tip to enhance the chemical process. In someembodiments of the invention, handpiece 220 includes a motor 234 tocontrol syringe 236, so that the amount of liquid can be deliveredaccurately, for example a drop every few seconds. In some embodiments ofthe invention, other materials may be delivered for various purposes,for example anesthetics, Lidocaine, Epinephrine, growth factors, stemcells, or Botulinum toxin.

In some embodiments of the invention, needle 240 is covered or coatedwith an insulator 260 so that the DC current will be delivered moreaccurately—only at the tip of needle 240. Alternatively, the DC currentmay be delivered by contact with skin 100 along the entire length ofneedle 240.

In an exemplary embodiment of the invention, handpiece 220 includes oneor more RF transmitters 232 that provide a high frequencyelectromagnetic radiation directed toward skin 100. Optionally, whendeploying needle 240 into skin 100 RF transmitters 232 are used to heatthe position where the chemical process is occurring to speed up thechemical process. Optionally, RF radiation may be applied continuouslyto keep the area warm or may be applied simultaneously when DC voltageis applied or separately only when the DC voltage is turned off. In someembodiments of the invention, the RF radiation only provides enough heatto enhance the effectiveness of the chemical process. Alternatively, theRF radiation may provide enough heat to destroy cells on its own, forexample by thermolysis using cauterization or coagulation, in additionto the chemical process that is induced by the DC voltage.

Optionally, the application of both DC voltage and RF radiationsimultaneously or intermittently reduces the time required to achievethe desired result, and may reduce the required current, for exampleusing 0.2 to 0.7 milliamp instead of 0.5 to 1 milliamp.

In an exemplary embodiment of the invention, device 200 includes anelectrical unit 210 for providing electrical power and controlling thefunction of handpiece 220. Optionally, electrical unit 210 is coupled tohandpiece 220 by way of an electrical cable 226. In an exemplaryembodiment of the invention, electrical unit 210 includes a DC currentsupply 222 to provide regulated negative voltage to needle 240. In anexemplary embodiment of the invention, DC current supply 222 provides aconstant current regardless of the load, so that the current is notaffected by resistance changing during treatment.

Additionally, electrical unit 210 may include an AC current source toprovide current to RF transmitters 232 or the RF transmitter may bepower by DC current. In an exemplary embodiment of the invention, ananode 230 is connected by a cable 228 to electrical unit 210. Anode 230is held by or attached to the person being treated to form a closedelectrical circuit through the body of the person being treated.

In some embodiments of the invention, electrical unit 210 includes aresistance sensor that measures the resistance through the DC circuitbetween needle 240 that serves as the cathode, and anode 230.Optionally, the resistance value may be displayed on a display 214 ormay give off audible signals (e.g. more rapid or less rapid) or otherindications, so that the user of device 200 may estimate the depth ofneedle 240 based on the signals, since the resistance of the skin 100differs at different depths.

In some embodiments of the invention, electrical unit 210 may include aprocessor or logic circuit to facilitate a control unit 218. Optionally,control unit 218 may include several programs for controlling the deviceand the user selects the desired program, for example by settingswitches or dials 212. In some embodiments of the invention, controlunit 218 is programmable. Optionally, device 200 can be connected to acomputer (e.g. through an I/O port) to receive commands regarding thecontrol of device 200.

Optionally, the functions controlled by control unit 218 may include thefollowing:

1. Display of status details on display 214;

2. Provision of power (e.g. DC or AC) to various units of the device;

3. Controlling the syringe motor 234;

4. Controlling the provision of saline to the syringe;

5. Providing audible signals;

6. Controlling timing of the electrical signals so that they will besynchronized relative to each other.

In an exemplary embodiment of the invention, the DC signal may providedifferent amounts of current for different lengths of time dependingupon the position being treated in the skin, for example when treatingmuscles and muscle nerves control 218 may apply a direct current of 1-2milliamp for the duration of 10-30 seconds, whereas when treating fat inthe subcutaneous level a direct current of 0.1-0.8 milliamps for 5-15seconds may be used.

In an exemplary embodiment of the invention, handpiece 220 includes aneedle positioning motor 270. Optionally, needle positioning motor 270automatically positions the X-Y-Z coordinates of the needle relative tohandpiece 220, so that the needle can be accurately and automaticallycontrolled when handpiece 220 is held stationary. The use of needlepositioning motor 270 allows better accuracy than achievable by apractitioner moving handpiece 220 manually.

In an exemplary embodiment of the invention, more than one needle 240may be used to increase the number of points that are treatedsimultaneously. FIG. 3 is a schematic illustration of an alternativehand piece 300 with an array of needles 340, according to an exemplaryembodiment of the invention. Optionally, array 340 may be provided inany shape and with any number of needles. Optionally, the needles may beequally spaced or unequally spaced. Additionally, the needles may form asymmetrical pattern or a non-symmetrical pattern. In some embodiments ofthe invention, each needle may be controlled separately or groups ofneedles from the array may be controlled together to form specifictreatment patterns.

FIG. 4 is a schematic illustration summarizing a cosmetic skin treatmentprocess 400 using device 200, according to an exemplary embodiment ofthe invention. As shown in FIG. 4 initially the user deploys (410)needle 240 to the desired depth in a person's skin 100. The desireddepth may depend on the type of treatment being performed and/or on thearea of the body being treated, for example epidermis 20 in the face andneck is 100 microns thick and dermis 30 is 1900 microns thick. In otherparts of the body the epidermis and dermis may be thicker or less thickthan these values. Optionally, needle 240 is designed to allowpenetration of about 1-12 mm. Optionally, device 200 provides the userwith an indication of the position in the skin 100 based on the measuredresistance between the cathode and the anode. Alternatively oradditionally, the user is required to recognize the depth to whichneedle 240 is deployed based on human anatomy. Once needle 240 ispositioned the user may apply (420) a negative DC voltage to needle 240for a pre-selected length of time with a pre-selected level of current,for example the voltage may be between 1 to 40 Volts, current between0.1 to 1 milliamp and time may be between 1 to 1 to 30 seconds. In anexemplary embodiment of the invention, the user sets selection dials 212to select the desired parameters and have them applied automatically andaccurately by device 100 when pressing an activation button afterdeploying needle 240.

In an exemplary embodiment of the invention, the penetration depth isdetermined by measuring the current or resistance of the circuit, sincethe resistance varies depending on the penetration depth or tissuelayer. In some embodiments of the invention, the resistance is measuredbefore treatment and after treatment to determine the level of successin damaging the targeted area.

In an exemplary embodiment of the invention, the parameters appliedduring the treatment depend upon many attributes, for example:

1. The type of skin flaw being treated (e.g. stains, wrinkles, scars,keloids, fat, tattoos);

2. The tolerance to pain of the person being treated;

3. The skin and tissue sensitivity of the person being treated;

4. The area being treated;

Optionally, the user may instruct device 200 to add Saline (430) orother liquids to enhance the success of the treatment. The DC voltagecauses electrolysis to take place at the point of contact of needle 240in the person's skin 100. The electrolysis releases Sodium and HydroxylIons that are attracted to needle 240 causing them to combine and form(440) an Alkali: Sodium Hydroxide (NaOH). The Sodium Hydroxide iscaustic and destroys cells surrounding the point of contact. The SodiumHydroxide will be formed as a drop at the tip of the needle or along thenon-insulated length of the needle. As a result the process causesprecise damage to the selected layer below the surface of skin 100without leaving noticeable markings on the outer layer of skin 100.

In an exemplary embodiment of the invention, device 200 includes RFtransmitters that produce radiation directed toward the area beingtreated causing heat to be applied (450) to the area being treated.Optionally, the RF transmitters transmit at frequencies between therange of 0.5 to 40 Mhz so that the radiation is felt as heat in theperson's skin 100. Optionally the heat accelerates the production ofSodium Hydroxide and/or assist in destroying cells surrounding the pointof contact.

In an exemplary embodiment of the invention, the destruction process isapplied (460) for a pre-selected amount of time (e.g. based on the sizeof the area needed to be ablated). Optionally, needle 240 may be used asa suction to remove (470) unwanted fluids, for example melted fat. Aftertreating a specific area the user may remove (480) the needle and moveit to treat a new location. Optionally, if using array 340 a larger areamay be treated simultaneously instead of a single point. In some casesit may be advantageous to quickly cover a larger area, although in othercases pin point accuracy may be desired.

In some embodiments of the invention, needle positioning motor 270controls the movement of each needle or a group of needles. Optionally,needle positioning motor 270 is programmed to treat a specific areawhile automatically controlling the spatial (X-Y-Z) coordinates ofneedle 240.

FIG. 8A is a schematic illustration of a single injection needle 240performing electrolysis, according to method 400 as described above.FIG. 8B is a schematic illustration of an array of injection needles 340performing electrolysis, according to method 400 as described above. InFIG. 8A needle 240 is covered with an insulation 260 and the chemicalprocess is limited to the non-insulated area at the tip of needle 240.In contrast in FIG. 8B the needles of array 340 are not insulated so thechemical process occurs along the length of the needles in the skin,limited by the moisture gradient, wherein the deeper layers are moisterthan the upper layers so that more Sodium Hydroxide forms at the lowerlayers.

In some embodiments of the invention, device 200 and process 400 isapplied to the ablation of muscles 50 and muscle nerve cells, forexample as a substitute to using Botox to remove wrinkles from aperson's forehead or from other places on the face or body of theperson. Optionally, damaging muscles 50 and muscle nerve cells will havethe effect of causing muscle 50 to lapse, like when using Botox butwithout the need to apply toxic materials. Alternatively oradditionally, Botox may be applied (e.g. through the hollow of needle240), for example in a smaller amount, while using the above process.Optionally, Botox may be applied in addition to the application ofSaline. In some embodiments of the invention, other materials may beused for example medication to prevent infection.

FIG. 5 is a schematic illustration of a side sectional view of skin 100with needle 240 deployed for treating muscles 50 below the subcutaneouslayer 40, according to an exemplary embodiment of the invention.

In some embodiments of the invention, device 200 and process 400 may beapplied to the reduction of fat cells from the subcutaneous layer 40.Optionally, needle 240 may be used without insulation 260 or with lessinsulation to expand the area that is affected by the DC current.Optionally, this process may be used to perform liposuction. In anexemplary embodiment of the invention, needle 240 is positioned in theperson's skin 100 and used to melt down fat cells. The fat cells areemulsified into an oily liquid substance, and are disposed of by thenatural body waste disposal processes. Optionally, the hollow of needle240 is used to suck out the melted cells. In some embodiments of theinvention, the hollow of needle 240 is used to inject medication, forexample a Tumescent solution that consists of Lidocaine and Epinephrine.Lidocaine serves as a local anesthetic and Epinephrine leads to theconstriction of blood vessels leading to less blood loss and lessbruising. Optionally, the use of needle 240 with DC current may reducethe need to use medication or even cancel the need.

FIG. 6 is a schematic illustration of a side sectional view of skin 100with needle 240 deployed for treating fatty areas in the subcutaneouslayer, according to an exemplary embodiment of the invention.

In some embodiments of the invention, device 200 and process 400 may beapplied to damage collagen fibers from the dermis 30. Optionally, needle240 is inserted onto collagen fibers 70 and used to destroy them. Thedamage in the dermis 30 stimulates the body's natural healing process toproduce new healthier skin 100 and collagen 70. In some embodiments ofthe invention, the heat produced by RF transmitters 232 results incollagen contraction leading to collagen regeneration and skintightening. The combined effect of collagen contraction and woundhealing rejuvenates skin 100. The fact that the ablation is pin pointedand the damaged areas are surrounded by healthy tissue speeds up thehealing process and minimizes downtime of the person being treated.

FIG. 7 is a schematic illustration of a side sectional view of skin 100with needle 240 deployed for treating collagen 70 in the dermal layer,according to an exemplary embodiment of the invention.

In an exemplary embodiment of the invention, the fact that the moisturegradient in skin tissue layers is such that moisture concentration ishigher in the deeper layers minimizes the damage to the upper skinlayers whether the upper part of needle 240 is covered by insulation 260or not. Optionally, the skin surface will show no signs of the chemicalprocess except the needle entry mark. Thus even when using the array ofneedles 340 or inserting needle 240 multiple times, skin 100 will showvery little signs of treatment unless specifically aiming for the upperlayer and using saline to enhance the process. In contrast a method thatuses needles charged with AC current tends to cause excessive heatingduring treatment and leaves scar marks due to fat emulsification.

In an exemplary embodiment of the invention, treatment of the innerlayers of skin 100 by the above methods cause the skin to becometemporarily red with mild swelling but does not lead to skin peeling orrequire patient downtime.

In an exemplary embodiment of the invention, a number of experimentswere conducted to test certain aspects of the device and methodsdescribed above.

In a first experiment the efficiency of the above method was tested byexamining the effect on egg white.

An egg white of a fresh egg was placed inside a glass jar. Twoelectrodes were glued to two opposite inner walls of the jar. Theelectrodes were connected to an AC current supply generator of 1 MHzfrequency and a power of approximately 5 Watt.

A third electrode was connected to the positive pole of a DC currentsource. This electrode was inserted into the jar. A fourth electrode wasconnected at one side to a needle such as used for hair removal byepilation. The needle diameter was 0.003 inch; manufactured by Ballet,model F3. The other side of the electrode was connected to thenegatively charged (cathode) pole of the DC source.

In the first stage of the experiment only DC current was applied. Thiscaused initial destruction of the egg white surrounding the needle. Thetime duration was measured from activation of the DC current until theformation of a white layer of dead cells around the needle.

In the second stage of the experiment, both DC and AC current wereapplied simultaneously. This caused initial destruction of the egg whitesurrounding the needle. Again, time duration was measured from thecurrent activation until the formation of a white layer of dead cellsaround the needle.

The time duration measured in the first stage was found to be 2-4 timeslonger than the time measured in the second stage. Another observationconcluded that the amount of dead cells surrounding the needle tip wassignificantly larger than the amount of dead cells along the needle.

In a second experiment the above methods were tested on animal tissue(flesh and fat) when applying combined currents, DC and/or AC, with orwithout saline solution injection.

Pork bacon slices were placed on a glass plate. A video camera wasplaced beneath the glass plate and the experiment was video filmed. A DCcurrent operating at a voltage of V volts and a current intensity of Amilliamp was used. A Dermatic1 mesotherapy gun from Euromi with asyringe, catheters and non-insulated needles were used to perform theexperiment. The negative (cathode) electrode of the DC source wasconnected to the syringe needle. The positive (anode) electrode of theDC source was connected to the mesotherapy gun in order to close theelectric loop. An AC current source operating at a frequency of 1 MHzand a power of W was used. The AC current was used to create an RFradiation field between two electrodes attached to the pork slice. Themesotherapy syringe needle was injected into the slice between the twoAC electrodes. The mesotherapy syringe needle was injected into theslice at a penetration depth of approximately 1-2 mm for a duration timeof up to 1 minute. The mesotherapy gun contained saline solution forinjection into the slice.

The following scenarios were examined:

1. Syringe needle injection with no saline solution, no DC current, noAC current;

2. Syringe needle injection with no saline solution, with DC current, noAC current;

3. Syringe needle injection with saline solution, with DC current, no ACcurrent;

4. Syringe needle injection with no saline solution, with DC current,with AC current;

5. Syringe needle injection with saline solution, with DC current, withAC current.

The following results were observed:

1. Scenario 1—No effect on slice except the forming of a needle hole.

2. Scenario 2—The DC current flowing through the needle caused achemical reaction in the slice. A small region surrounding the needlewas emulsified into oily liquid. A hole was formed in the tissue whereit was emulsified. The process took approximately 1 minute. In viewingthe video recording it can be seen that the initial effect is fatemulsification into liquid. In the next stage emulsification results ina small hole in the tissue which eventually grows larger and larger.

3. Scenario 3—Injection of saline solution into the slice intensifiedthe chemical reaction. Emulsification occurred faster and on a largerscale creating a larger region of emulsification surrounding the needle.A hole was formed in the tissue where the tissue was emulsified.

4. Scenario 4—The AC current intensified the chemical reactiondramatically causing much faster emulsification and on a larger regionsurrounding the needle.

5. Scenario 5—Injection of saline solution into the slice intensifiedthe chemical reaction. Emulsification occurred faster and on a largerregion. A hole was formed in the tissue where the tissue had emulsified.In this scenario the effect was the most profound.

Conclusions:

The most effective method for emulsifying flesh and fat is usingscenario 5 which gave the most dramatic effect. The flesh and fat shouldbe moist. Saline solution may be injected into the treated area in orderto moisten the area. The injected needle should be charged with anegative DC current and the surrounding treatment zone should beradiated by a high frequency AC signal.

It should be appreciated that the above described methods and apparatusmay be varied in many ways, including omitting or adding steps, changingthe order of steps and the type of devices used. It should beappreciated that different features may be combined in different ways.In particular, not all the features shown above in a particularembodiment are necessary in every embodiment of the invention. Furthercombinations of the above features are also considered to be within thescope of some embodiments of the invention.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather the scope of the present invention isdefined only by the claims, which follow.

We claim:
 1. A cosmetic method for treating a skin of a person,comprising: inserting one or more needles to one or more depths into theskin of the person such that at least a tip of at least one needle ofthe one or more needles is deployed within a muscle layer of theperson's skin; providing a DC power source electrically coupled to theone or more needles; applying a negative DC voltage to the one or moreneedles from said DC power source, and a positive DC voltage to anelectrode in contact with a surface of the skin of the person to formone or more closed circuits of constant DC current through the person'sbody; and providing the negative and positive DC current voltages havinga pre-selected value for a pre-selected amount of time, the preselectedvalue and amount of time being configured to induce a cold chemicalprocess in the cells surrounding the one or more needles that causesselective destruction of cells including damaging and/or ablatingmuscles and/or muscle nerve cells in the muscle layer; thereby providinga skin treatment comprising causing the muscles in the muscle layer tolapse and reducing and/or smoothing wrinkles from the person's skin. 2.The method according to claim 1, wherein said person's skin comprisesface skin and/or forehead of the person.
 3. The method according toclaim 1, further comprising supplying one or more substances into theskin through a hollow conduit formed in said one or more needles toenhance the skin treatment process.
 4. The method according to claim 3,wherein said one or more substances comprise one or more of thefollowing: anesthetics, lidocaine, epinephrine, growth factors, stemcells, and botulinum toxin.
 5. The method according to claim 1, furthercomprising measuring electrical resistance through the one or morecircuits enabling to determine the one or more depths, and providing anindication of the one or more depths to the user.
 6. The methodaccording to claim 5, wherein the electrical resistance is measuredbefore and after treatment to determine the level of success of thetreatment.
 7. The method according to claim 1, further comprising:inserting at least one second needle of the one or more needles to asecond depth into the skin of the person such that at least a tip of theat least one second needle is deployed within a collagen fiber region ina dermis tissue layer; the skin treatment thereby comprising damagingthe collagen fiber(s) and stimulating a natural healing process andproduction of new collagen fibers.
 8. The method according to claim 1,further comprising: inserting at least one third needle of the one ormore needles to a third depth into the skin of the person such that atleast a tip of the at least one third needle is deployed in a vicinityof fat cells in the subcutaneous layer; the skin treatment therebycomprising melting down the fat cells and reducing fat from thesubcutaneous layer.
 9. The method according to claim 8, furthercomprising: sucking out the melted fat cells through a hollow conduitformed in said at least one third needle.
 10. The method of claim 1,wherein said one or more needles are partially insulated and the tips ofthe one or more needles are not insulated.
 11. The method of claim 1,further comprising providing same or different respective one or more DCcurrents through the person's body.
 12. The method according to claim 1,further comprising: providing one or more radio frequency (RF)transmitters; and transmitting RF radiation from the one or more RFtransmitters towards the treated skin of the person to thereby heat thetreated skin and enhance the skin treatment.
 13. The method according toclaim 12, wherein said forming of the DC current and said transmittingof the RF radiation are performed simultaneously.
 14. The methodaccording to claim 12, wherein said forming of the DC current and saidtransmitting of the RF radiation are performed intermittently.
 15. Acosmetic method for treating a face skin of a person, comprising:inserting one or more needles into the face skin of the person such thatat least a tip of at least one needle of the one or more needles isdeployed within a muscle layer of the person's face skin; providing a DCpower source electrically coupled to the one or more needles; providingone or more radio frequency (RF) transmitters; applying a negative DCvoltage to the one or more needles from said DC power source, and apositive DC voltage to an electrode in contact with a surface of theskin of the person to form one or more closed circuits of constant DCcurrent through the person's body; transmitting RF radiation from theone or more RF transmitters towards the treated face skin of the personto thereby heat the treated face skin; and providing: the negative andpositive DC voltages and the RF radiation in a pre-selected timing, thenegative and positive DC voltages configured to induce a cold chemicalprocess in the cells surrounding the one or more needles that causesselective destruction of cells, and the RF radiation configured to heatthe tissue surrounding the needles, thereby damaging and/or ablatingmuscles and/or muscle nerve cells in the muscle layer; thereby providinga face skin treatment comprising reducing and/or smoothing wrinkles fromthe person's face skin.
 16. The method according to claim 15, whereinsaid forming of the constant DC current and said transmitting of the RFradiation are performed simultaneously.
 17. The method according toclaim 15, wherein said forming of the DC current and said transmittingof the RF radiation are performed intermittently.